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Sichuan Kelun-Biotech Gains NMPA Approval for SKB107 Bone Metastasis Trial
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate SKB107, formerly known as TBM-001. The study will focus on advanced solid tumor bone metastasis. Drug Development and MechanismSKB107 is a radionuclide…
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Abbisko Therapeutics Receives NMPA Approval for ACH Drug ABSK061
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its FGFR2/3 inhibitor ABSK061. The approval paves the way for a multi-center, non-randomized, open Phase I/II study to evaluate the drug’s safety, tolerability, pharmacokinetics, and efficacy in children…
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AstraZeneca Officially Launches Fasenra for Severe Eosinophilic Asthma in China
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UK-based pharmaceutical giant AstraZeneca Inc. (NASDAQ: AZN) has announced the official market launch of its monoclonal antibody Fasenra (benralizumab) in China. The drug is approved as a maintenance therapy for severe eosinophilic asthma (SEA) in adults and adolescents aged 12 and above. Clinical Trial and ApprovalFasenra received marketing approval in…
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United Laboratories Inks Global Licensing Deal with Novo Nordisk for Obesity Drug
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has entered into a licensing agreement with Denmark’s Novo Nordisk A/S (NYSE: NVO). The deal grants Novo Nordisk global development, manufacturing, and commercialization rights to United Laboratories’ UBT251, excluding China mainland, Hong Kong, Macau, and Taiwan, where United Laboratories retains the…
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Joint Biosciences’ OVV-01 Receives FDA Fast Track Designation for Soft Tissue Sarcoma Trial
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Shanghai-based Joint Biosciences Ltd., a developer of tumor combined immunotherapies, has announced receiving fast track designation from the US Food and Drug Administration (FDA) for its Phase II study of OVV-01. This recombinant vesicular stomatitis virus (VSV) carrying the NY-ESO-1 tumor-associated antigen is being investigated for the treatment of advanced…
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Sino Biopharmaceutical’s Culmerciclib Shows Positive Results in Phase III Breast Cancer Trial
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has revealed positive results from the Phase III TQB3616-III-02 study for its Category 1 drug culmerciclib (TQB3616) combined with fulvestrant. The trial focused on naïve patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast…
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Humanwell Healthcare Receives NMPA Approval for Caplyta Generic in Schizophrenia Trial
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its generic version of US-based Intra-Cellular Therapies’ Caplyta (lumateperone). This Category 3 chemical drug, with no similar product approved in China, is set for evaluation in schizophrenia treatment.…
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China’s NHSA Releases 2024 Healthcare Security Bulletin Highlighting Insurance Coverage and Reimbursement
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China’s National Healthcare Security Administration (NHSA) has released its 2024 “Healthcare Security Development Statistical Bulletin.” The report reveals that by the end of 2024, over 1.33 billion people were enrolled in Basic Medical Insurance (BMI) schemes, maintaining a coverage rate of over 95%. Maternity insurance participation reached 252.98 million, an…
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SineuGene Therapeutics’ SNUG01 Receives FDA Clearance for ALS Clinical Study
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Beijing-based SineuGene Therapeutics, a developer of gene therapies for brain disorders, announced last week that it has received clearance from the US Food and Drug Administration (FDA) to conduct a clinical study for its lead candidate SNUG01. This best-in-class (BIC) TRIM72-targeted gene therapy will be evaluated for the treatment of…
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GSK’s Nucala Accepted for EMA Review for COPD Treatment
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UK-based GSK plc’s (LON: GSK, NYSE: GSK) application for expanding the use of its anti-interleukin-15 (IL-15) biologic Nucala (mepolizumab) has been accepted for review by the European Medicines Agency (EMA). The proposed new use is as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) who have…
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Shanghai Ark Biopharmaceutical’s AK0901 Meets Phase III Endpoints in ADHD Trial
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China’s Shanghai Ark Biopharmaceutical Co., Ltd. has announced the completion of a Phase III study evaluating the efficacy, safety, and tolerability of its AK0901 in Chinese children aged 6-12 with Attention Deficit Hyperactivity Disorder (ADHD). The trial successfully achieved both primary and key secondary endpoints, demonstrating statistical significance at all…
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Suzhou Xueji Biotech’s XJ-MK-002 Gets FDA Orphan Drug Designation for CAMT
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China-based cell therapy developer Suzhou Xueji Biotechnology Co., Ltd’s (HemaCell) XJ-MK-002, described as the world’s first platelet-related cell therapy, received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) last week. The designation is for the treatment of congenital amegakaryocytic thrombocytopenia (CAMT), a rare hereditary bone marrow…
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Beijing Sungen Biomedical’s SGC001 Receives FDA Fast Track Designation for AMI Treatment
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China-based Beijing Sungen Biomedical Technology Co., Ltd, an antibody developer incubated by Hotgen Biotech Co., Ltd (SHA: 688068), has announced receiving Fast Track Designation from the United States Food and Drug Administration (FDA) for its SGC001, which is described as the world’s first acute myocardial infarction (AMI) antibody drug. Drug…
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AllianThera Biopharma Starts Global Phase I Trial for ATB102 in Inflammatory Bowel Diseases
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Suzhou-based startup AllianThera Biopharma has announced the first patient dosing in a global Phase I clinical study for its investigational drug ATB102. The trial, a randomized, double-blinded, placebo-controlled, dose-escalation study, is designed to evaluate the safety, tolerability, and pharmacokinetics of ATB102 in healthy subjects. Drug Mechanism and InnovationATB102 is an…
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Jiangsu Hengrui Pharmaceuticals’ Ivarmacitinib Receives NMPA Approval for Ankylosing Spondylitis
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its JAK1 inhibitor ivarmacitinib. The drug is now approved for use in treating adult patients with active ankylosing spondylitis (AS) who have had poor efficacy or intolerance to one or…
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Kexing Biopharm Partners with BioMap on AI-Driven Macromolecular Drug Development
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China-based Kexing Biopharm Co., Ltd. (SHA: 688136) announced a partnership with US biotech firm BioMap last week. The collaboration aims to develop macromolecular drugs targeting tumors and autoimmune diseases using AI technology. BioMap, an AI-based drug discovery platform, was founded by Chinese internet giant Baidu’s CEO Robin Li and Baidu…
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CStone Pharmaceuticals Files for EMA Approval of Sugemalimab for Unresectable Stage III NSCLC
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China-based CStone Pharmaceuticals (HKG: 2616) has announced filing for another indication approval for its anti-programmed death-ligand 1 (PD-L1) inhibitor sugemalimab (trade name: Cejemly) with the European Medicines Agency (EMA). The application seeks approval for sugemalimab’s use in patients with unresectable stage III non-small cell lung cancer (NSCLC) who have not…
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Clover Biopharmaceuticals Receives FDA Approval for SCB-1019 RSV Vaccine Trial
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China-based Clover Biopharmaceuticals Ltd., (HKG: 2197) has announced receiving clinical approval from the US Food and Drug Administration (FDA) for its SCB-1019, a non-adjuvanted bivalent RSV prefusion-stabilized F (PreF)-Trimer subunit vaccine candidate. The company has initiated the first subjects for the Phase I revaccination study, assessing the safety, reactogenicity, and…
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AIM Vaccine’s mRNA-based Shingles Vaccine Receives FDA Approval for Clinical Study
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its mRNA-based shingles vaccine. This marks a significant milestone in the company’s efforts to develop innovative vaccine solutions for global markets. Pre-Clinical Study ResultsIn pre-clinical…
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FDA Issues Second CRL to Hengrui’s Camrelizumab Combo Due to Manufacturing Issues
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The US Food and Drug Administration (FDA) last week issued another complete response letter (CRL) to China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) regarding its application for the combination of programmed death-1 (PD-1) monoclonal antibody (mAb) camrelizumab with small-molecule targeted cancer therapy apatinib as a first-line treatment for irresectable…
